Acute Coronary SyndromeNCT04455568
Establish a Telecare Model of Acute Coronary Syndrome Patient With Heart Stent Implantation by a Non-invasive Wearable Device and Artificial Intelligence Cloud to Reducing Medical Adverse Events.
An observational study of Acute Coronary Syndrome and Percutaneous Transluminal Coronary Angioplasty, run by Taipei Medical University Shuang Ho Hospital.
Trial summary
Heart disease is still one of the world's most important health problems, and it ranks second among the top ten causes of death among Taiwan. The main cause of death is acute coronary syndrome, and vascular stent placement is the main treatment method for acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Percutaneous Transluminal Coronary Angioplasty
- What is being tested?
- use EKG Wisdom bracelet
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2020to 20 Jul 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).
Who may be able to join
- ≥ 20-year-old
- Patients performing general metal stent surgery
- Diagnosis of Acute Coronary Syndrome
- Willing to sign the consent form of the subject and cooperate with the return visit
- Those who are admitted to the hospital and enter the general ward can receive the first ECG heart sound examination
Who cannot join
- <20-year-old
- Before the stent was installed, the same blood vessel had been used in patients with PCI (percutaneous coronary intervention) and CABG (Coronary artery bypass graft).
- Those who cannot perform the first examination after being admitted to the hospital and entering the general ward
- It is impossible to measure the group of ECG and heart sounds. For example, when using Pacemaker, the ECG showed ventricular tachycardia (VT) and Dextrocardia on admission.
- Patients who are bedridden and have difficulty in cooperating with return visits
- Any subject that the physician believes is at high risk for future uncooperative tracking
- Direct participants in this program
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Establish a Telecare Model of Acute Coronary Syndrome Patient With Heart Stent Implantation by a Non-invasive Wearable Device and Artificial Intelligence Cloud System to Heart Failure Monitoring and Reducing Medical Adverse Events.
Heart disease is still one of the world's most important health problems, and it ranks second among the top ten causes of death among Taiwan. The main cause of death is acute coronary syndrome, and vascular stent placement is the main treatment method for acute coronary syndrome. The probability of restenosis in patients within half a year after a general stent is as high as 25% to 40%. Re-hospitalization and surgery is a big burden on patients and the country's medical costs. However, a set of convenient and accurate clinical tools to determine the prognosis of patients has not yet been developed. Miniaturized wearable devices have been the mainstream trend in medical development in recent years. ECG and heart sound analysis technology are an easy to used medical device for automatically calculating the parameters including EMAT (electromechanical activation time), S4, S4, SDI (Systolic dyssynchrony index). ECG and heart sound could evaluate the heart function, and has the potential to be an effective tools for prognosis and treatment guidelines. Heart rate variability (HRV) and Accelerationplethysmogram (APG) is also proved the predictive effect the outcome of patients.
This study is start on June 1 2020. We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery, and registry there medical history,routine examination and medication, ECG and heart, HRV and APG record at admission, pre-discharge and every routine return visit within I year after discharge.Patients will also wear ECG and PPG (Photoplethysmography) band ever day after discharge, and collected the longitutinal data .All subjects will be tracked the medical adverse events in 1 years after discharge, and compare the characteristic and prognosis value of between patients with and without events. Therefore, our purpose of this study is to drive an effective outcome prediction model by non-invasive device, and establish a telecare model of patient with heart stent implantation to reducing medical adverse events.
Read the detailed description
This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive research. This study is start on June 1 2020. We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).
Ask whether the patients who meet the exclusion criteria are willing to participate in the screening (Screening), if they are willing to join and sign the consent of the subject, and after the patient's condition is stable, conduct an electrocardiogram (V0) before discharge from the hospital. On day 7 (±2 weeks), day 84 (±4 weeks), 168 days (±4 weeks), 252 days (±4 weeks), 336 days (±8 weeks) during routine clinical referral (V1-V5) Both are done once. The results of these two tests and other basic information of the patient, including Demography, Vital Signs, High, Weight, Medication, and European and Taiwan Cardiology Association recommended routine test results of high-risk patients, including Blood Chemistry Panel, NT-proBNP, Echocardiography, Myocardial Perfusion Scan, etc., will record the information of the logged-in subjects on the paper case report form. The CRF (case report form) only displays the study number, and no subject is available. In addition to the examination of each return visit, the subjects also took the ECG bracelet home at the time of discharge (V0) and wore it every day. After the discharge, the ECG was measured every morning and evening, and their personal activity and sleep were collected. Relevant information. After the subject was discharged from the hospital, the subject tracked the date of all adverse events due to cardiovascular disease within one year, including: heart failure, restenosis due to blood vessel, and non-fatal myocardial infarction , To do blood vessel-related surgery again, and data on the occurrence of death.
- Being tested
- use EKG Wisdom bracelet
- Keywords
- Artificial Intelligence, Non-invasive Wearable Device, Telecare Model of Patient,, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use EKG Wisdom braceletDevice
Also called control group (routine medical)
Non-invasive Wearable Device (use EKG Wisdom bracelet)
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Non-invasive Wearable Device, use ECG Wisdom bracelet Receives: Device: use EKG Wisdom bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death
Measured: Within a year
Restenosis
Restenosis
Measured: Within a year
heart failure
heart failure
Measured: Within a year
Secondary outcomes (7)
heart disease re-hospitalization
heart disease re-hospitalization
Measured: Within a year
Stroke re-hospitalization
Stroke re-hospitalization
Measured: Within a year
Arrhythmia re-hospitalization
Arrhythmia re-hospitalization
Measured: Within a year
Physician adjusts medicine
Physician adjusts medicine
Measured: Within a year
Physician arranges examination early
Physician arranges examination early
Measured: Within a year
Medical Compliance
Judged by the physician, when the patient returns to the consultation, the patient is asked about the compliance with the drug in the past, divided into presence and absence
Measured: Within a year
Medical Costs
The sum of all medical and health insurance expenses of the patient in the past year
Measured: Within a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start20 Jul 2020 (estimated)
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Hospital, Taipei Medical University, Lotung Poh-Ai Hospital
- Responsible party
- Sponsor
- Investigators
- Ju-Chi Liu, MD, Principal investigator, Chief, Internal of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455568
- Sponsor's protocol ID
- N202004123
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a Telecare Model of Acute Coronary Syndrome Patient With Heart Stent Implantation by a Non-invasive Wearable Device and Artificial Intelligence Cloud System to Heart Failure Monitoring and Reducing Medical Adverse Events.
- ClinicalTrials.gov ID
- NCT04455568
- Acronym / sponsor ID
- N202004123
- Keywords
- Artificial Intelligence, Non-invasive Wearable Device, Telecare Model of Patient,, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University WanFang Hospital, Taipei Medical University Hospital, Taipei Medical University, Lotung Poh-Ai Hospital
- Study start
- 20 Jul 2020 (estimated)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart disease is still one of the world's most important health problems, and it ranks second among the top ten causes of death among Taiwan. The main cause of death is acute coronary syndrome, and vascular stent placement is the main treatment method for acute coronary syndrome. The probability of restenosis in patients within half a year after a general stent is as high as 25% to 40%. Re-hospitalization and surgery is a big burden on patients and the country's medical costs. However, a set of convenient and accurate clinical tools to determine the prognosis of patients has not yet been developed. Miniaturized wearable devices have been the mainstream trend in medical development in recent years. ECG and heart sound analysis technology are an easy to used medical device for automatically calculating the parameters including EMAT (electromechanical activation time), S4, S4, SDI (Systolic dyssynchrony index). ECG and heart sound could evaluate the heart function, and has the potential to be an effective tools for prognosis and treatment guidelines. Heart rate variability (HRV) and Accelerationplethysmogram (APG) is also proved the predictive effect the outcome of patients.
This study is start on June 1 2020. We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery, and registry there medical history,routine examination and medication, ECG and heart, HRV and APG record at admission, pre-discharge and every routine return visit within I year after discharge.Patients will also wear ECG and PPG (Photoplethysmography) band ever day after discharge, and collected the longitutinal data .All subjects will be tracked the medical adverse events in 1 years after discharge, and compare the characteristic and prognosis value of between patients with and without events. Therefore, our purpose of this study is to drive an effective outcome prediction model by non-invasive device, and establish a telecare model of patient with heart stent implantation to reducing medical adverse events.
Detailed description
This study is open, prospective study, multi-center, randomized controlled trial, unobtrusive research. This study is start on June 1 2020. We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).
Ask whether the patients who meet the exclusion criteria are willing to participate in the screening (Screening), if they are willing to join and sign the consent of the subject, and after the patient's condition is stable, conduct an electrocardiogram (V0) before discharge from the hospital. On day 7 (±2 weeks), day 84 (±4 weeks), 168 days (±4 weeks), 252 days (±4 weeks), 336 days (±8 weeks) during routine clinical referral (V1-V5) Both are done once. The results of these two tests and other basic information of the patient, including Demography, Vital Signs, High, Weight, Medication, and European and Taiwan Cardiology Association recommended routine test results of high-risk patients, including Blood Chemistry Panel, NT-proBNP, Echocardiography, Myocardial Perfusion Scan, etc., will record the information of the logged-in subjects on the paper case report form. The CRF (case report form) only displays the study number, and no subject is available. In addition to the examination of each return visit, the subjects also took the ECG bracelet home at the time of discharge (V0) and wore it every day. After the discharge, the ECG was measured every morning and evening, and their personal activity and sleep were collected. Relevant information. After the subject was discharged from the hospital, the subject tracked the date of all adverse events due to cardiovascular disease within one year, including: heart failure, restenosis due to blood vessel, and non-fatal myocardial infarction , To do blood vessel-related surgery again, and data on the occurrence of death.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Device: use EKG Wisdom braceletNon-invasive Wearable Device, use ECG Wisdom bracelet |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll 400 patients who diagnosis of acute coronary syndrome and have been a heart stent surgery. And random allocation 200 experimental group (Non-invasive Wearable Device) and 200 control group (routine medical).
Key inclusion criteria (5 listed)
- ≥ 20-year-old
- Patients performing general metal stent surgery
- Diagnosis of Acute Coronary Syndrome
- Willing to sign the consent form of the subject and cooperate with the return visit
- Those who are admitted to the hospital and enter the general ward can receive the first ECG heart sound examination
Key exclusion criteria (7 listed)
- <20-year-old
- Before the stent was installed, the same blood vessel had been used in patients with PCI (percutaneous coronary intervention) and CABG (Coronary artery bypass graft).
- Those who cannot perform the first examination after being admitted to the hospital and entering the general ward
- It is impossible to measure the group of ECG and heart sounds. For example, when using Pacemaker, the ECG showed ventricular tachycardia (VT) and Dextrocardia on admission.
- Patients who are bedridden and have difficulty in cooperating with return visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use EKG Wisdom braceletAlso: control group (routine medical)Non-invasive Wearable Device (use EKG Wisdom bracelet) | Device | experimental group |
Primary outcome
death
Time frame: Within a year
death
Restenosis
Time frame: Within a year
Restenosis
heart failure
Time frame: Within a year
heart failure
7 secondary outcomes
heart disease re-hospitalization
Time frame: Within a year
Stroke re-hospitalization
Time frame: Within a year
Arrhythmia re-hospitalization
Time frame: Within a year
Physician adjusts medicine
Time frame: Within a year
Physician arranges examination early
Time frame: Within a year
Medical Compliance
Time frame: Within a year
Medical Costs
Time frame: Within a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Chi Liu, MD principal investigator
Chief, Internal of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Percutaneous Transluminal Coronary Angioplasty, run by Taipei Medical University Shuang Ho Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju-Chi Liu, MD (886-2-22490088 ext. 8170, liumdcv@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: Within a year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.